Esophageal Cancer Clinical Trial

Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.

View Full Description

Full Description

OBJECTIVES:

Primary

Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.

Secondary

Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. Patients undergo tumor resection on day 0.

After completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus

Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0)
Stage I-III disease
No known distant metastases
No cervical-esophageal tumors (upper border < 18 cm from the incisor teeth)
No supraclavicular metastases

PATIENT CHARACTERISTICS:

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Adequate bone marrow function

Hepatic

Adequate hepatic function
No unstable or uncompensated hepatic disease

Renal

Creatinine ≤ grade 2 by Common Toxicity Criteria
Adequate renal function
No unstable or uncompensated renal disease

Cardiovascular

No unstable or uncompensated cardiac disease

Pulmonary

No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes
No unstable or uncompensated respiratory disease

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No known hypersensitivity to gefitinib or any of the excipients
No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix
No evidence of severe or uncontrolled systemic disease
No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Endocrine therapy

Concurrent stable-dose steroids allowed

Surgery

Recovered from any prior oncologic or other major surgery

Other

More than 30 days since prior nonapproved or investigational drug
No prior therapy for this or any other malignancy
No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00258297

Recruitment Status:

Terminated

Sponsor:

University of Rochester

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00258297

Recruitment Status:

Terminated

Sponsor:


University of Rochester

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider